Quality Provider of Generics and Finished Dosage Formulations

About Us

Regulatory Affairs

To remain compliant with regulatory requirements across different markets and manage the regulatory life cycle of our various products, we have an experienced and dedicated teams of regulatory professionals with focused expertise in different geographic regions, including USA, Canada, Europe and RoW markets. Having a seamlessly integrated and fully compliant manufacturing operations in line with regulatory agencies’ guidelines is the first and foremost priority for us and our regulatory team is committed to put in all efforts to achieve this. The team ensures that all our dossiers are of the best quality and of highest accuracy to get timely approvals and effective commercial launch.

Our manufacturing facilities are routinely inspected / accredited by the most stringent international regulatory agencies like USFDA, EU, Japan PMDA, EMEA, TGA Australia, ANVISA Brazil, PIC/S, SAHPRA South Africa, WHO etc., and as an organization we are committed to maintain adherence to cGMP compliance at all times.

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